MigraineCOPCNCT05752396
Overlapping Pain Trajectory Study
An observational study of Migraine and Musculoskeletal Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Musculoskeletal Pain, Functional Abdominal Pain Disorders
- What is being tested?
- Conditioned Pain Modulation, Offset Analgesia and Spatial Summation
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents with localized and overlapping pain conditions
Who may be able to join
- General Criteria
- Access to the internet either by laptop, tablet, or phone (for REDCap Surveys)
- English-speaking
- Parent or guardian willing to comply with protocol, complete study assessments, and provide written informed consent
- Control Specific Criteria
- No history/active chronic pain
Show all 9Show fewer
- Patient Specific Criteria
- Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), or diffuse MSK (widespread MSK pain)
- If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.
Who cannot join
- General Criteria
- Skin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testing
- Any comorbid rheumatic disease (e.g., arthritis, lupus), neurological (e.g., epilepsy, traumatic brain injury) or medical condition (e.g., cancer, diabetes)
- Control Specific Criteria
- Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric)
- Patient Specific Criteria
- Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Christopher D King, Ph.D., 5138032391, christopher.king@cchmc.org
Kacie Peters, B.S., 513-517-0594, Kacie.Peters@cchmc.org
About this study
Official title: Disrupted Spatial and Temporal Nociceptive Filtering in Adolescents With and Risk for Overlapping Pain Conditions
The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are:
- If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls.
- If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth.
Participation includes:
- quantitative sensory testing
- blood draw
- sleep assessment
- questionnaires
Read the detailed description
While localized primary pain conditions are prevalent in youth, a significant subset of these patients experience multiple pain conditions and meet the criteria for chronic overlapping pain conditions (COPCs). COPCs have a marked negative impact on daily functioning and quality of life in youth and carry a high risk for continued pain and disability into adulthood. The underlying factors contributing to the development and persistence of COPCs in youth are unknown. The current proposal offers an innovative and previously unexplored approach to determine whether disruptions in spatial (concurrent noxious stimuli across the body) and temporal (noxious stimuli presented over time) filtering of nociceptive processing, reflecting pain amplification (e.g., increased facilitation and/or reduced inhibition), contribute to COPCs. Several quantitative sensory testing methods are uniquely positioned to probe disruptions in nociceptive filtering across spatial (spatial summation, SS; conditioned pain modulation, CPM) and temporal (temporal summation, TS; offset analgesia, OFA) domains. Our recent pilot studies found evidence for greater disruptions in spatial (CPM) and temporal (TS) filtering in youth with COPCs. Our primary objective is to determine if spatial and temporal filtering of nociceptive information differentiates youth with COPCs from those with localized pain and healthy controls and determine whether distinct profiles of disrupted nociceptive processing are associated with the transition of localized pain to COPCs. To accomplish this, the current study will leverage expertise and a vast clinical infrastructure (Migraine, Gastroenterology, Rheumatology and Pain Management clinics) at a large pediatric medical center to enroll 140 youth with a localized pain condition (migraine, abdominal pain, local MSK), and 140 youth with COPC's. 140 healthy youth will also recruited to serve as a control group. Following initial phenotyping to delineate disruptions in spatial and temporal dimensions of nociceptive processing (Aim 1), participants will be assessed for changes in pain status (localized to COPCs) every three months for one year (Aim 2). In Aim 1, it is hypothesized that youth with COPCs will show disrupted spatial (reflected by reduced CPM and enhanced SS) and temporal (reflected by enhanced TS and reduced OFA) processing compared to youth with localized pain and healthy controls. These findings will delineate specific disruptions of nociceptive processing in patients with COPCs. For Aim 2, it is hypothesized that a subset of youth with localized pain and disrupted spatial and temporal filtering will develop COPCs. The stability of spatial and temporal filtering will be examined at clinically relevant time points. The investigators will also explore whether other factors, including concomitant treatments, influence the disrupted filtering and the transition to COPCs. Our research will provide the first insight into the presence and impact of disrupted nociceptive filtering related to COPCs and its naturalistic progression from localized pain. This information will be critical in identifying risk patterns that can be useful in the prevention of progression to COPCs and mitigating long-term risk.
- Conditions
- Migraine, Musculoskeletal Pain, Functional Abdominal Pain Disorders, Chronic Pain, Widespread Chronic Pain, Low Back Pain
- Being tested
- Conditioned Pain Modulation, Offset Analgesia, Spatial Summation, Temporal Summation
- Medical subject headings
- Migraine Disorders, Musculoskeletal Pain, Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioned Pain ModulationOther
Conditioned pain modulation (CPM) procedure evaluates the change in mechanical and heat pain sensitivity by a contralateral conditioning stimulus (cold immersion). This psychophysical paradigm investigates inhibitory pain modulation processes.
Offset AnalgesiaOther
Offset analgesia (OFA) procedure evaluates the disproportionate change in heat pain sensitivity after a slight decrease in stimulus intensity. This psychophysical paradigm investigates inhibitory pain modulation processes.
Spatial SummationOther
Spatial summation (SS) procedure evaluates the change in heat pain sensitivity when applying two painful stimuli simultaneously compared to one stimulus alone. This psychophysical paradigm investigates facilitatory pain modulation processes.
Temporal SummationOther
Temporal summation (TS) procedure evaluates the change in mechanical pain sensitivity after exposure to a series of noxious stimuli of the same intensity. This psychophysical paradigm investigates facilitatory pain modulation processes.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Pain - Localized | Patients with localized pain conditions (n=140) Receives: Other: Conditioned Pain Modulation; Other: Offset Analgesia; Other: Spatial Summation; Other: Temporal Summation | |
| Chronic Pain - Overlapping | Patients with two or more pain conditions (n=140) Receives: Other: Conditioned Pain Modulation; Other: Offset Analgesia; Other: Spatial Summation; Other: Temporal Summation | |
| Healthy Participants | Health Participants without a chronic pain condition (n=140) Receives: Other: Conditioned Pain Modulation; Other: Offset Analgesia; Other: Spatial Summation; Other: Temporal Summation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation (CPM) Profile (Pressure)
-CPM is defined by the change in pressure thresholds (increase) before and during cold immersion. Pressure thresholds will be measured using an algometer.
Measured: Baseline, 3 months, and 12 months
Conditioned Pain Modulation (CPM) Profile (Heat)
-CPM is defined by the change in heat pain intensity (decrease) before and during cold immersion. Heat stimuli will be delivered by a thermode and pain intensity measured by participant self report on the visual analog scale.
Measured: Baseline, 3 months, and 12 months
Offset Analgesia (OA) Profile
OFA is defined by the change in heat pain intensity (decrease) after a slight reduction in stimulus intensity (1 Deg C). Heat stimuli will be delivered by a thermode and pain intensity measured continuously during stimuli by participant self report on the computerized visual analog scale.
Measured: Baseline, 3 months, and 12 months
Temporal Summation (TS) Profile
TS is defined by the change in mechanical pain intensity (increase) after exposure to a series of pinprick stimuli. Pain intensity will be measured by participant self report on the visual analog scale.
Measured: Baseline, 3 months, and 12 months
Spatial Summation (SS) Profile
SS is defined by the change (increase) in heat pain intensity between two simultaneously applied thermodes compared to one stimulus thermode only. Pain intensity will be measured by participant self report on the visual analog scale.
Measured: Baseline, 3 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher D. King, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752396
- Sponsor's protocol ID
- 2022-0260
- Acronym
- COPC
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Discussing options with IRB.
Publications
Coghill RC. The distributed nociceptive system: a novel framework for understanding pain. Scand J Pain. 2022 Sep 22;22(4):679-680. doi: 10.1515/sjpain-2022-0097. Print 2022 Oct 26.
PubMed 36129140Quevedo AS, Coghill RC. Attentional modulation of spatial integration of pain: evidence for dynamic spatial tuning. J Neurosci. 2007 Oct 24;27(43):11635-40. doi: 10.1523/JNEUROSCI.3356-07.2007.
PubMed 17959806Quevedo AS, Coghill RC. Filling-in, spatial summation, and radiation of pain: evidence for a neural population code in the nociceptive system. J Neurophysiol. 2009 Dec;102(6):3544-53. doi: 10.1152/jn.91350.2008. Epub 2009 Sep 16.
PubMed 19759320Nahman-Averbuch H, Schneider VJ 2nd, Chamberlin LA, Kroon Van Diest AM, Peugh JL, Lee GR, Radhakrishnan R, Hershey AD, Powers SW, Coghill RC, King CD. Identification of neural and psychophysical predictors of headache reduction after cognitive behavioral therapy in adolescents with migraine. Pain. 2021 Feb 1;162(2):372-381. doi: 10.1097/j.pain.0000000000002029.
PubMed 32773592Szikszay TM, Levenez JLM, von Selle J, Adamczyk WM, Luedtke K. Investigation of Correlations Between Pain Modulation Paradigms. Pain Med. 2021 Sep 8;22(9):2028-2036. doi: 10.1093/pm/pnab067.
PubMed 33587117Maixner W, Fillingim RB, Williams DA, Smith SB, Slade GD. Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification. J Pain. 2016 Sep;17(9 Suppl):T93-T107. doi: 10.1016/j.jpain.2016.06.002.
PubMed 27586833Ohrbach R, Sharma S, Fillingim RB, Greenspan JD, Rosen JD, Slade GD. Clinical Characteristics of Pain Among Five Chronic Overlapping Pain Conditions. J Oral Facial Pain Headache. 2020;34(Suppl):s29-s42. doi: 10.11607/ofph.2573.
PubMed 32975539
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disrupted Spatial and Temporal Nociceptive Filtering in Adolescents With and Risk for Overlapping Pain Conditions
- ClinicalTrials.gov ID
- NCT05752396
- Acronym / sponsor ID
- COPC / 2022-0260
- Conditions
- Migraine, Musculoskeletal Pain, Functional Abdominal Pain Disorders, Chronic Pain, Widespread Chronic Pain, Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are:
- If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls.
- If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth.
Participation includes:
- quantitative sensory testing
- blood draw
- sleep assessment
- questionnaires
Detailed description
While localized primary pain conditions are prevalent in youth, a significant subset of these patients experience multiple pain conditions and meet the criteria for chronic overlapping pain conditions (COPCs). COPCs have a marked negative impact on daily functioning and quality of life in youth and carry a high risk for continued pain and disability into adulthood. The underlying factors contributing to the development and persistence of COPCs in youth are unknown. The current proposal offers an innovative and previously unexplored approach to determine whether disruptions in spatial (concurrent noxious stimuli across the body) and temporal (noxious stimuli presented over time) filtering of nociceptive processing, reflecting pain amplification (e.g., increased facilitation and/or reduced inhibition), contribute to COPCs. Several quantitative sensory testing methods are uniquely positioned to probe disruptions in nociceptive filtering across spatial (spatial summation, SS; conditioned pain modulation, CPM) and temporal (temporal summation, TS; offset analgesia, OFA) domains. Our recent pilot studies found evidence for greater disruptions in spatial (CPM) and temporal (TS) filtering in youth with COPCs. Our primary objective is to determine if spatial and temporal filtering of nociceptive information differentiates youth with COPCs from those with localized pain and healthy controls and determine whether distinct profiles of disrupted nociceptive processing are associated with the transition of localized pain to COPCs. To accomplish this, the current study will leverage expertise and a vast clinical infrastructure (Migraine, Gastroenterology, Rheumatology and Pain Management clinics) at a large pediatric medical center to enroll 140 youth with a localized pain condition (migraine, abdominal pain, local MSK), and 140 youth with COPC's. 140 healthy youth will also recruited to serve as a control group. Following initial phenotyping to delineate disruptions in spatial and temporal dimensions of nociceptive processing (Aim 1), participants will be assessed for changes in pain status (localized to COPCs) every three months for one year (Aim 2). In Aim 1, it is hypothesized that youth with COPCs will show disrupted spatial (reflected by reduced CPM and enhanced SS) and temporal (reflected by enhanced TS and reduced OFA) processing compared to youth with localized pain and healthy controls. These findings will delineate specific disruptions of nociceptive processing in patients with COPCs. For Aim 2, it is hypothesized that a subset of youth with localized pain and disrupted spatial and temporal filtering will develop COPCs. The stability of spatial and temporal filtering will be examined at clinically relevant time points. The investigators will also explore whether other factors, including concomitant treatments, influence the disrupted filtering and the transition to COPCs. Our research will provide the first insight into the presence and impact of disrupted nociceptive filtering related to COPCs and its naturalistic progression from localized pain. This information will be critical in identifying risk patterns that can be useful in the prevention of progression to COPCs and mitigating long-term risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic Pain - Localized | – | Other: Conditioned Pain Modulation, Other: Offset Analgesia, Other: Spatial Summation, Other: Temporal SummationPatients with localized pain conditions (n=140) |
| Chronic Pain - Overlapping | – | Other: Conditioned Pain Modulation, Other: Offset Analgesia, Other: Spatial Summation, Other: Temporal SummationPatients with two or more pain conditions (n=140) |
| Healthy Participants | – | Other: Conditioned Pain Modulation, Other: Offset Analgesia, Other: Spatial Summation, Other: Temporal SummationHealth Participants without a chronic pain condition (n=140) |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with localized and overlapping pain conditions
Key inclusion criteria (9 listed)
- General Criteria
- Control Specific Criteria
- Patient Specific Criteria
Key exclusion criteria (7 listed)
- General Criteria
- Control Specific Criteria
- Patient Specific Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioned Pain ModulationConditioned pain modulation (CPM) procedure evaluates the change in mechanical and heat pain sensitivity by a contralateral conditioning stimulus (cold immersion). This psychophysical paradigm investigates inhibitory pain modulation processes. | Other | Chronic Pain - Localized, Chronic Pain - Overlapping, Healthy Participants |
| Offset AnalgesiaOffset analgesia (OFA) procedure evaluates the disproportionate change in heat pain sensitivity after a slight decrease in stimulus intensity. This psychophysical paradigm investigates inhibitory pain modulation processes. | Other | Chronic Pain - Localized, Chronic Pain - Overlapping, Healthy Participants |
| Spatial SummationSpatial summation (SS) procedure evaluates the change in heat pain sensitivity when applying two painful stimuli simultaneously compared to one stimulus alone. This psychophysical paradigm investigates facilitatory pain modulation processes. | Other | Chronic Pain - Localized, Chronic Pain - Overlapping, Healthy Participants |
| Temporal SummationTemporal summation (TS) procedure evaluates the change in mechanical pain sensitivity after exposure to a series of noxious stimuli of the same intensity. This psychophysical paradigm investigates facilitatory pain modulation processes. | Other | Chronic Pain - Localized, Chronic Pain - Overlapping, Healthy Participants |
Primary outcome
Conditioned Pain Modulation (CPM) Profile (Pressure)
Time frame: Baseline, 3 months, and 12 months
-CPM is defined by the change in pressure thresholds (increase) before and during cold immersion. Pressure thresholds will be measured using an algometer.
Conditioned Pain Modulation (CPM) Profile (Heat)
Time frame: Baseline, 3 months, and 12 months
-CPM is defined by the change in heat pain intensity (decrease) before and during cold immersion. Heat stimuli will be delivered by a thermode and pain intensity measured by participant self report on the visual analog scale.
Offset Analgesia (OA) Profile
Time frame: Baseline, 3 months, and 12 months
OFA is defined by the change in heat pain intensity (decrease) after a slight reduction in stimulus intensity (1 Deg C). Heat stimuli will be delivered by a thermode and pain intensity measured continuously during stimuli by participant self report on the computerized visual analog scale.
Temporal Summation (TS) Profile
Time frame: Baseline, 3 months, and 12 months
TS is defined by the change in mechanical pain intensity (increase) after exposure to a series of pinprick stimuli. Pain intensity will be measured by participant self report on the visual analog scale.
Spatial Summation (SS) Profile
Time frame: Baseline, 3 months, and 12 months
SS is defined by the change (increase) in heat pain intensity between two simultaneously applied thermodes compared to one stimulus thermode only. Pain intensity will be measured by participant self report on the visual analog scale.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 36129140Coghill RC. The distributed nociceptive system: a novel framework for understanding pain. Scand J Pain. 2022 Sep 22;22(4):679-680. doi: 10.1515/sjpain-2022-0097. Print 2022 Oct 26.
- Background: PubMed 17959806Quevedo AS, Coghill RC. Attentional modulation of spatial integration of pain: evidence for dynamic spatial tuning. J Neurosci. 2007 Oct 24;27(43):11635-40. doi: 10.1523/JNEUROSCI.3356-07.2007.
- Background: PubMed 19759320Quevedo AS, Coghill RC. Filling-in, spatial summation, and radiation of pain: evidence for a neural population code in the nociceptive system. J Neurophysiol. 2009 Dec;102(6):3544-53. doi: 10.1152/jn.91350.2008. Epub 2009 Sep 16.
- Background: PubMed 32773592Nahman-Averbuch H, Schneider VJ 2nd, Chamberlin LA, Kroon Van Diest AM, Peugh JL, Lee GR, Radhakrishnan R, Hershey AD, Powers SW, Coghill RC, King CD. Identification of neural and psychophysical predictors of headache reduction after cognitive behavioral therapy in adolescents with migraine. Pain. 2021 Feb 1;162(2):372-381. doi: 10.1097/j.pain.0000000000002029.
- Background: PubMed 33587117Szikszay TM, Levenez JLM, von Selle J, Adamczyk WM, Luedtke K. Investigation of Correlations Between Pain Modulation Paradigms. Pain Med. 2021 Sep 8;22(9):2028-2036. doi: 10.1093/pm/pnab067.
- Background: PubMed 27586833Maixner W, Fillingim RB, Williams DA, Smith SB, Slade GD. Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification. J Pain. 2016 Sep;17(9 Suppl):T93-T107. doi: 10.1016/j.jpain.2016.06.002.
- Background: PubMed 32975539Ohrbach R, Sharma S, Fillingim RB, Greenspan JD, Rosen JD, Slade GD. Clinical Characteristics of Pain Among Five Chronic Overlapping Pain Conditions. J Oral Facial Pain Headache. 2020;34(Suppl):s29-s42. doi: 10.11607/ofph.2573.
- Individual participant dataSharing planned: Undecided. Discussing options with IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Musculoskeletal Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kacie Peters (513-517-0594, Kacie.Peters@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned Pain Modulation (CPM) Profile (Pressure) (time frame: Baseline, 3 months, and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752396, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.